Duke University Medical Center
Cognitive Behavioral Research and Treatment Program
Brain Stimulation Clinic and Research Program
Department of Psychiatry and Behavioral Neuroscience (3026)
Durham, NC 27710
Principal Investigator: Andrada D. Neacsiu, PhD, Assistant Professor
Department of Psychiatry and Behavioral Neuroscience, 919-684-6714
Introductory statement: The purpose of this Information Statement is to introduce you to a research study and to provide you with enough information to decide whether or not you are interested in filling out the following screening questionnaire.
We are conducting a research study and your answers on this screening questionnaire may indicate that our study is a good fit for you. If your answers on the screening questionnaire indicate that the study may be a good fit for you, someone from our lab will contact you. At that time you will have a chance to review your answers to the screening questions, and you will be provided with a brief summary of the research study we are screening for. You will have the option to decline participation in the study, or to participate in the process of informed consent. You will have the opportunity to ask questions about the purpose of the research, what we would ask you to do, the possible risks and benefits, your rights as a volunteer, and anything else about the research that is not clear. If the study is not a good fit, someone from our lab will also contact you to provide you with additional information and referrals as needed.
Purpose of the study: The purpose of our research is to assess the effects of combining two different interventions (behavioral skills training and non-invasive brain stimulation) for persons who report having difficulties regulating emotions and who meet criteria for a mental health disorder.
Study Procedures: If you choose to participate, you will be asked to complete the 4- page screening questionnaire that follows, and to provide your name and contact information. An example of the kinds of questions you will be asked to answer would be to report if you are currently in psychotherapy, if you have ever been diagnosed with a mental health disorder (or believe you have a mental health disorder), or whether you've been recently hospitalized for psychiatric reasons. You can choose to skip any questions that you do not want to answer and you can end your participation at any point by closing the survey. This survey can take 10 to 20 minutes to complete.
Risks, Stress, or Discomfort: The screening questionnaire may be stressful for some people. Some individuals may experience increased emotional discomfort as they are reminded of past or present problems while they answer the questions. Please call 911 should your discomfort become extreme.
Other risks include potential risks of breaches of confidentiality that may occur if someone sees you filling in the on line survey or on the telephone calls following this on line survey. Situations that occur may include: someone overhearing you talking to our team, or someone hearing a phone message or reading a letter from our clinic intended for you. You may feel like your privacy has been violated in these instances. We try to prevent these breaches of confidentiality from occurring by making sure that our staff only leave their names and the name of the institution (‘Duke University Medical Center’voice mailil messages and that they use general Duke University Medical Center envelopes.
Benefits of the Study: There are no anticipated benefits to your participation in this screening. However, if you are selected for the study, you may benefit from treatment. If you are not selected for the study, you also may benefit from a referral to a treatment provider.
Other Information: Participation in this study is voluntary. You can stop or withdraw at any time. Choosing to take part in the study, or to not take part in the study, will not affect benefits to which you are otherwise entitled. For example, you can contact us for a referral regardless if you answer the screening questions or not. You can also do the screening by phone if you do not want to complete the on line questionnaire. The number to call for both referrals and phone screening is 919-684-6714.
Information about you is confidential. All the information you provide in the screener questionnaire will be separated from your name and telephone number and the link as well as all other information that you will provide to us will be kept in a secured database. All identifiable information will be deleted immediately if you do not qualify for the study no later than 9/1/2020. We will destroy any identifiable information earlier, at your request, if you decide you do not want to participate in the study. All research information will be kept indefinitely.
By filling out the attached screening questionnaire and providing your contact information, you are consenting to participate in this study. If you do not wish to take part in the study and are not interested in our larger project, please do not fill out the screening questionnaire.
The TMS-CR research team.